AnxietyNCT07712978
Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward
A study testing Mothers' Heartbeat Intervention in people with Anxiety and Stress, run by Mervi Hakala at 1 site in Finland.
Trial summary
Neonatal jaundice is a common condition among newborns and may require phototherapy during the early postnatal period. Although phototherapy is an effective treatment for hyperbilirubinemia, it may be associated with maternal stress, anxiety, concern and disruption of closeness between the mother and newborn. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anxiety, Stress, Experience
- What is being tested?
- Mothers' Heartbeat Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 3 Jul 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The mother has given birth at the study hospital.
- The mother's newborn requires phototherapy for neonatal jaundice during postnatal care in the maternity ward.
- The newborn is born at term, between 37+0 and 41+6 gestational weeks.
- Phototherapy is provided in a normal patient room or family room in the maternity ward where the mother or parents room-in with the newborn.
- The mother is able to understand Finnish.
- The mother is able to provide informed consent.
- The mother is willing to participate in the study.
Who cannot join
- Mothers are excluded if any of the following criteria apply:
- Sensory impairment affecting participation, including significant visual or hearing impairment.
- Inability to understand Finnish.
- Postpartum complications requiring special attention or care, including pre-eclampsia, complicated infection or spinal headache.
- Newborns are excluded if any of the following criteria apply:
- Phototherapy is started within 24 hours after birth.
Show all 9Show fewer
- Phototherapy is started at night.
- The newborn receives home phototherapy.
- The newborn is born before 37+0 gestational weeks or after 41+6 gestational weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward: A Mixed Methods Feasibility Study
Neonatal jaundice is a common condition among newborns and may require phototherapy during the early postnatal period. Although phototherapy is an effective treatment for hyperbilirubinemia, it may be associated with maternal stress, anxiety, concern and disruption of closeness between the mother and newborn. This mixed methods feasibility study evaluates a mothers' heartbeat intervention designed to support maternal well-being and newborn comfort during phototherapy in a maternity ward setting.
The intervention uses a multisensory sleep pad placed under the newborn's mattress during phototherapy. At the beginning of the intervention, each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel these individually recorded maternal sounds and vibrations while lying on the mattress. The intervention is intended to provide womb-like auditory and tactile stimulation and to promote calmness, comfort and a sense of closeness during treatment.
Read more
The study includes mothers whose term newborns require phototherapy for jaundice at a maternity ward in Finland. A total of 40 mothers and newborns are included: 20 in the intervention group and 20 in the control group. Data are collected before and after phototherapy. Maternal outcomes include anxiety, stress and experience of phototherapy. The feasibility, usability and acceptability of the intervention are assessed among mothers in the intervention group. In addition, semi-structured interviews are conducted to explore mothers' experiences of successful factors related to the intervention.
The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is acceptable, usable and feasible in a maternity ward during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. The findings will be used to inform the planning of a future larger randomized controlled trial.
Read the detailed description
Neonatal jaundice is one of the most common conditions requiring treatment during the early postnatal period. Phototherapy is an effective and widely used treatment for neonatal hyperbilirubinemia, but the treatment situation may be stressful for mothers. During phototherapy, the newborn may need to remain under phototherapy lights or on a phototherapy blanket for prolonged periods, which may limit normal closeness, skin-to-skin contact and uninterrupted interaction between the mother and newborn. Mothers may experience stress, anxiety, concern and uncertainty related to their newborn's condition, treatment procedures and the need to maintain effective phototherapy exposure.
This mixed methods feasibility study evaluates a mothers' heartbeat intervention during newborn phototherapy in a maternity ward setting. The intervention is designed to provide individually recorded maternal auditory and tactile stimulation to the newborn during phototherapy and to support maternal well-being, newborn comfort and maternal-newborn closeness. The intervention uses a multisensory sleep pad placed under the newborn's mattress. At the beginning of the intervention, the mother's heartbeat, breathing sounds and chest vibrations are recorded. These individually recorded maternal sounds and vibrations are transferred to the sleep pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress.
The intervention is intended to create womb-like auditory and tactile stimulation and to provide a familiar maternal sensory environment during treatment. The newborn receives usual phototherapy care according to standard clinical practice, and the mothers' heartbeat intervention is used as an additional supportive intervention. The newborn remains in phototherapy as much as possible to achieve the intended treatment effect, and usual care activities such as feeding, diaper changing and drying are carried out according to normal maternity ward routines.
The study is conducted as a mixed methods feasibility study with a quasi-experimental pilot design and qualitative interviews. A total of 40 mothers and their term newborns requiring phototherapy for jaundice are included. The intervention group includes 20 mothers and newborns who receive the mothers' heartbeat intervention in addition to usual phototherapy care. The control group includes 20 mothers and newborns who receive usual phototherapy care only. Data are collected in two consecutive periods from June 2024 to January 2025 in a university hospital maternity ward in Finland.
The study population consists of mothers whose newborns are born at 37+0 to 41+6 gestational weeks and require phototherapy for jaundice during postnatal care in the maternity ward. Phototherapy is provided in a normal patient room or family room where the mother or parents room-in with the newborn. Phototherapy may be delivered using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need and standard care.
The feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale after phototherapy. Maternal anxiety is measured before and after phototherapy using the State-Trait Anxiety Inventory, state anxiety form. Maternal stress is measured before and after phototherapy using a verbal rating scale for stress. Mothers' experience of phototherapy is assessed after phototherapy using a numerical rating scale. In addition, mothers in the intervention group participate in semi-structured interviews after phototherapy to explore their experiences of the successful factors related to the intervention.
The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is feasible, usable and acceptable in a maternity ward setting during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. Qualitative interview data are used to provide a deeper understanding of how mothers experience the intervention, including its perceived calming effects, user-friendliness and role as a facilitating element during phototherapy.
The findings from this feasibility study will inform the development and planning of a future larger randomized controlled trial. The study may provide preliminary evidence on whether a simple, non-invasive and individually tailored sensory intervention can support mothers and newborns during phototherapy and improve the care experience in maternity ward settings.
- Conditions
- Anxiety, Stress, Experience
- Being tested
- Mothers' Heartbeat Intervention
- Keywords
- feasibility study, mixed methods, phototherapy, jaundice, newborn, stress, anxiety, experience, mother
- Medical subject headings
- Anxiety Disorders, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers' Heartbeat InterventionDevice
The mothers' heartbeat intervention consists of individually recorded maternal heartbeat, breathing sounds and chest vibrations delivered to the newborn through a multisensory Nucu Pad placed under the mattress during phototherapy. The intervention is used in addition to usual phototherapy care.
| Study group | Role | What they receive |
|---|---|---|
| Mothers' Heartbeat Intervention | Experimental | Participants in this arm receive the mothers' heartbeat intervention in addition to usual phototherapy care. The intervention uses a multisensory Nucu Pad placed under the newborn's mattress. Each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress. Receives: Device: Mothers' Heartbeat Intervention |
| Usual Phototherapy care | No intervention | Participants in this arm receive usual phototherapy care only according to standard maternity ward practice. Phototherapy may be provided using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, usability and acceptability of the mothers' heartbeat intervention
Feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale (SUS). The SUS includes 10 items rated on a 5-point Likert scale from "strongly disagree" to "strongly agree". The total SUS score ranges from 0 to 100, with higher scores indicating better usability and acceptability.
Measured: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Secondary outcomes (5)
Maternal anxiety
Maternal anxiety is assessed using the State-Trait Anxiety Inventory, state anxiety form (STAI-Y1). The measure includes 20 items assessing the mother's current anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety. Anxiety is classified as low, moderate or high according to the total score.
Measured: Baseline -Before phototherapy
Maternal stress
Maternal stress is assessed using a verbal rating scale for stress (VRSS). Mothers rate their stress on a 0-5 scale ranging from "I did not feel any stress at all" to "I felt the worst stress I can think of". Higher scores indicate higher perceived stress.
Measured: Baseline -Before phototherapy
Maternal experience of phototherapy
Mothers evaluate their overall experience of newborn phototherapy using a numerical rating scale (NRS) from 0 to 10, where 0 indicates a very negative experience and 10 indicates a very positive experience. Higher scores indicate a more positive phototherapy experience.
Measured: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Maternal anxiety
Maternal anxiety is assessed using the State-Trait Anxiety Inventory, state anxiety form (STAI-Y1). The measure includes 20 items assessing the mother's current anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety. Anxiety is classified as low, moderate or high according to the total score.
Measured: After completion of phototherapy, approximately 24 hours after the start of phototherapy.
Maternal stress
Maternal stress is assessed using a verbal rating scale for stress (VRSS). Mothers rate their stress on a 0-5 scale ranging from "I did not feel any stress at all" to "I felt the worst stress I can think of". Higher scores indicate higher perceived stress.
Measured: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start3 Jul 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized interventional feasibility study with a parallel assignment model. Participants were allocated to either an intervention group receiving the mothers' heartbeat intervention in addition to usual phototherapy care or a control group receiving usual phototherapy care only. Data were collected during two consecutive periods.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mervi Hakala
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Sponsor-investigator, Mervi Hakala, Oulu University Hospital
- Investigators
- Tarja Pölkki, Professor, Study director, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712978
- Sponsor's protocol ID
- EETTMK: 12/2024
- Other IDs
- 181/2024
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes a small sample of mothers and newborns and contains sensitive maternal and neonatal health-related data. The qualitative interview data may include contextual information that could increase the risk of participant identification, even after anonymization.
Publications
Zhang Q, Huo Q, Chen P, Yao W, Ni Z. Effects of white noise on preterm infants in the neonatal intensive care unit: A meta-analysis of randomised controlled trials. Nurs Open. 2024 Jan;11(1):e2094. doi: 10.1002/nop2.2094.
PubMed 38268285Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476van der Geest BAM, Theeuwen IM, Reiss IKM, Steegers EAP, Been JV. Assessing knowledge and skills of maternity care professionals regarding neonatal hyperbilirubinaemia: a nationwide survey. BMC Pregnancy Childbirth. 2021 Jan 19;21(1):63. doi: 10.1186/s12884-020-03463-0.
PubMed 33468082Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Siva N, Praharaj M, Tanay K, Das S, Nayak BS, Lewis LES, Noronha JA. Evidenced-Based Recommendation for Involving Mothers to Reduce the Procedural Pain and Stress in High-Risk Neonates: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Neonatal Care. 2025 Apr 1;25(2):103-112. doi: 10.1097/ANC.0000000000001247. Epub 2025 Mar 26.
PubMed 40048649Sarker S, Jahan F, Parvez SM, Shoab AKM, Hasan R, El Arifeen S, Billah SM, Hoque MM, Rahman M. Effectiveness of prenatal intervention on neonatal hyperbilirubinemia management in rural Bangladesh: Results from a cluster-randomized trial. Public Health. 2025 Jan;238:221-228. doi: 10.1016/j.puhe.2024.12.018. Epub 2024 Dec 16.
PubMed 39689650Pettersson M, Eriksson M, Odlind A, Ohlin A. Home phototherapy of term neonates improves parental bonding and stress: Findings from a randomised controlled trial. Acta Paediatr. 2022 Apr;111(4):760-766. doi: 10.1111/apa.16231. Epub 2021 Dec 28.
PubMed 34932853Pettersson M, Eriksson M, Blomberg K. Parental experiences of home phototherapy for neonatal hyperbilirubinemia. J Child Health Care. 2023 Dec;27(4):562-573. doi: 10.1177/13674935221082404. Epub 2022 Mar 26.
PubMed 35341337Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w.
PubMed 33292770Muchowski KE. Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam Physician. 2014 Jun 1;89(11):873-8.
PubMed 25077393Matvienko-Sikar K, Redsell S, Flannery C. Effects of maternal stress and/or anxiety interventions in the first 1000 days:Systematic review of reviews. J Reprod Infant Psychol. 2023 Apr;41(2):114-151. doi: 10.1080/02646838.2021.1976400. Epub 2021 Sep 23.
PubMed 34555958Coquery SS, Georges A, Cortey A, Floch C, Avran D, Gatbois E, Mehler-Jacob C, de Stampa M. Discharge of newborns with risk factors of severe hyperbilirubinemia: description of a hospital at home-based care monitoring and phototherapy. Eur J Pediatr. 2022 Aug;181(8):3075-3084. doi: 10.1007/s00431-022-04461-4. Epub 2022 Jun 13.
PubMed 35695955
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward: A Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT07712978
- Acronym / sponsor ID
- EETTMK: 12/2024
- Conditions
- Anxiety, Stress, Experience
- Keywords
- feasibility study, mixed methods, phototherapy, jaundice, newborn, stress, anxiety, experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mervi HakalaUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonatal jaundice is a common condition among newborns and may require phototherapy during the early postnatal period. Although phototherapy is an effective treatment for hyperbilirubinemia, it may be associated with maternal stress, anxiety, concern and disruption of closeness between the mother and newborn. This mixed methods feasibility study evaluates a mothers' heartbeat intervention designed to support maternal well-being and newborn comfort during phototherapy in a maternity ward setting.
The intervention uses a multisensory sleep pad placed under the newborn's mattress during phototherapy. At the beginning of the intervention, each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel these individually recorded maternal sounds and vibrations while lying on the mattress. The intervention is intended to provide womb-like auditory and tactile stimulation and to promote calmness, comfort and a sense of closeness during treatment.
The study includes mothers whose term newborns require phototherapy for jaundice at a maternity ward in Finland. A total of 40 mothers and newborns are included: 20 in the intervention group and 20 in the control group. Data are collected before and after phototherapy. Maternal outcomes include anxiety, stress and experience of phototherapy. The feasibility, usability and acceptability of the intervention are assessed among mothers in the intervention group. In addition, semi-structured interviews are conducted to explore mothers' experiences of successful factors related to the intervention.
The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is acceptable, usable and feasible in a maternity ward during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. The findings will be used to inform the planning of a future larger randomized controlled trial.
Detailed description
Neonatal jaundice is one of the most common conditions requiring treatment during the early postnatal period. Phototherapy is an effective and widely used treatment for neonatal hyperbilirubinemia, but the treatment situation may be stressful for mothers. During phototherapy, the newborn may need to remain under phototherapy lights or on a phototherapy blanket for prolonged periods, which may limit normal closeness, skin-to-skin contact and uninterrupted interaction between the mother and newborn. Mothers may experience stress, anxiety, concern and uncertainty related to their newborn's condition, treatment procedures and the need to maintain effective phototherapy exposure.
This mixed methods feasibility study evaluates a mothers' heartbeat intervention during newborn phototherapy in a maternity ward setting. The intervention is designed to provide individually recorded maternal auditory and tactile stimulation to the newborn during phototherapy and to support maternal well-being, newborn comfort and maternal-newborn closeness. The intervention uses a multisensory sleep pad placed under the newborn's mattress. At the beginning of the intervention, the mother's heartbeat, breathing sounds and chest vibrations are recorded. These individually recorded maternal sounds and vibrations are transferred to the sleep pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress.
The intervention is intended to create womb-like auditory and tactile stimulation and to provide a familiar maternal sensory environment during treatment. The newborn receives usual phototherapy care according to standard clinical practice, and the mothers' heartbeat intervention is used as an additional supportive intervention. The newborn remains in phototherapy as much as possible to achieve the intended treatment effect, and usual care activities such as feeding, diaper changing and drying are carried out according to normal maternity ward routines.
The study is conducted as a mixed methods feasibility study with a quasi-experimental pilot design and qualitative interviews. A total of 40 mothers and their term newborns requiring phototherapy for jaundice are included. The intervention group includes 20 mothers and newborns who receive the mothers' heartbeat intervention in addition to usual phototherapy care. The control group includes 20 mothers and newborns who receive usual phototherapy care only. Data are collected in two consecutive periods from June 2024 to January 2025 in a university hospital maternity ward in Finland.
The study population consists of mothers whose newborns are born at 37+0 to 41+6 gestational weeks and require phototherapy for jaundice during postnatal care in the maternity ward. Phototherapy is provided in a normal patient room or family room where the mother or parents room-in with the newborn. Phototherapy may be delivered using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need and standard care.
The feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale after phototherapy. Maternal anxiety is measured before and after phototherapy using the State-Trait Anxiety Inventory, state anxiety form. Maternal stress is measured before and after phototherapy using a verbal rating scale for stress. Mothers' experience of phototherapy is assessed after phototherapy using a numerical rating scale. In addition, mothers in the intervention group participate in semi-structured interviews after phototherapy to explore their experiences of the successful factors related to the intervention.
The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is feasible, usable and acceptable in a maternity ward setting during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. Qualitative interview data are used to provide a deeper understanding of how mothers experience the intervention, including its perceived calming effects, user-friendliness and role as a facilitating element during phototherapy.
The findings from this feasibility study will inform the development and planning of a future larger randomized controlled trial. The study may provide preliminary evidence on whether a simple, non-invasive and individually tailored sensory intervention can support mothers and newborns during phototherapy and improve the care experience in maternity ward settings.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized interventional feasibility study with a parallel assignment model. Participants were allocated to either an intervention group receiving the mothers' heartbeat intervention in addition to usual phototherapy care or a control group receiving usual phototherapy care only. Data were collected during two consecutive periods.
| Arm | Type | Receives |
|---|---|---|
| Mothers' Heartbeat Intervention | Experimental | Device: Mothers' Heartbeat InterventionParticipants in this arm receive the mothers' heartbeat intervention in addition to usual phototherapy care. The intervention uses a multisensory Nucu Pad placed under the newborn's mattress. Each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress. |
| Usual Phototherapy care | No intervention | –Participants in this arm receive usual phototherapy care only according to standard maternity ward practice. Phototherapy may be provided using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The mother has given birth at the study hospital.
- The mother's newborn requires phototherapy for neonatal jaundice during postnatal care in the maternity ward.
- The newborn is born at term, between 37+0 and 41+6 gestational weeks.
- Phototherapy is provided in a normal patient room or family room in the maternity ward where the mother or parents room-in with the newborn.
- The mother is able to understand Finnish.
Key exclusion criteria (9 listed)
- Sensory impairment affecting participation, including significant visual or hearing impairment.
- Inability to understand Finnish.
- Postpartum complications requiring special attention or care, including pre-eclampsia, complicated infection or spinal headache.
- Phototherapy is started within 24 hours after birth.
- Phototherapy is started at night.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothers' Heartbeat InterventionThe mothers' heartbeat intervention consists of individually recorded maternal heartbeat, breathing sounds and chest vibrations delivered to the newborn through a multisensory Nucu Pad placed under the mattress during phototherapy. The intervention is used in addition to usual phototherapy care. | Device | Mothers' Heartbeat Intervention |
Primary outcome
Feasibility, usability and acceptability of the mothers' heartbeat intervention
Time frame: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale (SUS). The SUS includes 10 items rated on a 5-point Likert scale from "strongly disagree" to "strongly agree". The total SUS score ranges from 0 to 100, with higher scores indicating better usability and acceptability.
5 secondary outcomes
Maternal anxiety
Time frame: Baseline -Before phototherapy
Maternal stress
Time frame: Baseline -Before phototherapy
Maternal experience of phototherapy
Time frame: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Maternal anxiety
Time frame: After completion of phototherapy, approximately 24 hours after the start of phototherapy.
Maternal stress
Time frame: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 38268285Zhang Q, Huo Q, Chen P, Yao W, Ni Z. Effects of white noise on preterm infants in the neonatal intensive care unit: A meta-analysis of randomised controlled trials. Nurs Open. 2024 Jan;11(1):e2094. doi: 10.1002/nop2.2094.
- Results publication: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Results publication: PubMed 33468082van der Geest BAM, Theeuwen IM, Reiss IKM, Steegers EAP, Been JV. Assessing knowledge and skills of maternity care professionals regarding neonatal hyperbilirubinaemia: a nationwide survey. BMC Pregnancy Childbirth. 2021 Jan 19;21(1):63. doi: 10.1186/s12884-020-03463-0.
- Results publication: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Results publication: PubMed 40048649Siva N, Praharaj M, Tanay K, Das S, Nayak BS, Lewis LES, Noronha JA. Evidenced-Based Recommendation for Involving Mothers to Reduce the Procedural Pain and Stress in High-Risk Neonates: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Neonatal Care. 2025 Apr 1;25(2):103-112. doi: 10.1097/ANC.0000000000001247. Epub 2025 Mar 26.
- Results publication: PubMed 39689650Sarker S, Jahan F, Parvez SM, Shoab AKM, Hasan R, El Arifeen S, Billah SM, Hoque MM, Rahman M. Effectiveness of prenatal intervention on neonatal hyperbilirubinemia management in rural Bangladesh: Results from a cluster-randomized trial. Public Health. 2025 Jan;238:221-228. doi: 10.1016/j.puhe.2024.12.018. Epub 2024 Dec 16.
- Results publication: PubMed 34932853Pettersson M, Eriksson M, Odlind A, Ohlin A. Home phototherapy of term neonates improves parental bonding and stress: Findings from a randomised controlled trial. Acta Paediatr. 2022 Apr;111(4):760-766. doi: 10.1111/apa.16231. Epub 2021 Dec 28.
- Results publication: PubMed 35341337Pettersson M, Eriksson M, Blomberg K. Parental experiences of home phototherapy for neonatal hyperbilirubinemia. J Child Health Care. 2023 Dec;27(4):562-573. doi: 10.1177/13674935221082404. Epub 2022 Mar 26.
- Results publication: PubMed 33292770Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w.
- Results publication: PubMed 25077393Muchowski KE. Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam Physician. 2014 Jun 1;89(11):873-8.
- Results publication: PubMed 34555958Matvienko-Sikar K, Redsell S, Flannery C. Effects of maternal stress and/or anxiety interventions in the first 1000 days:Systematic review of reviews. J Reprod Infant Psychol. 2023 Apr;41(2):114-151. doi: 10.1080/02646838.2021.1976400. Epub 2021 Sep 23.
- Results publication: PubMed 35695955Coquery SS, Georges A, Cortey A, Floch C, Avran D, Gatbois E, Mehler-Jacob C, de Stampa M. Discharge of newborns with risk factors of severe hyperbilirubinemia: description of a hospital at home-based care monitoring and phototherapy. Eur J Pediatr. 2022 Aug;181(8):3075-3084. doi: 10.1007/s00431-022-04461-4. Epub 2022 Jun 13.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes a small sample of mothers and newborns and contains sensitive maternal and neonatal health-related data. The qualitative interview data may include contextual information that could increase the risk of participant identification, even after anonymization.
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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarja Pölkki, Professor study director
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers' Heartbeat Intervention in people with Anxiety and Stress, run by Mervi Hakala at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, usability and acceptability of the mothers' heartbeat intervention (time frame: After completion of phototherapy, approximately 24 hours after the start of phototherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07712978, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.